Intensive Neurophysiological Rehabilitation System for children with cerebral palsy: a quasi-randomized controlled trial.

BACKGROUND: Recent research indicates that intensive rehabilitation tends to be effective for children with cerebral palsy (CP). Intensive Neurophysiological Rehabilitation System (INRS) is a multi-component approach that combines various interventions and addresses different functional goals.. This study aimed to examine the effectiveness of the INRS treatment in children with bilateral CP. METHODS: In this quasi-randomized controlled study, 48 children with spastic bilateral CP (age 5-12 years, GMFCS Levels I-IV, MACS Levels I-IV) were assigned to an experimental or control group in order they have been enrolled. The experimental group underwent INRS treatment in the tertiary care facility for about four hours daily for ten days and continued routine home treatment for four weeks. After the first evaluation, participants from the control group stayed on the waiting list for four weeks receiving home treatment and then starting the INRS treatment. Thereby, all participants were assessed three times. The primary outcome measure was a Gross Motor Function Measure 66 Item Set (GMFM). The secondary outcome measures included the Jebsen-Taylor Hand Function test, Box and Blocks test, ABILHAND-Kids Questionnaire, Self-care and Mobility domain of the Pediatric Evaluation of Disability Inventory, and the ankle dorsiflexion passive range of motion. RESULTS: There was a statistically significant increase in the GMFM score after the INRS treatment in both the experimental group (mean difference (MD) 2.0, P < 0.01) and control group (MD 1.5, P < 0.05), with a large size effect (partial eta squared (η2) = 0.21 and η2 = 0.14). The mean difference between groups during the first study period was 2.89 points (p < 0.01) in the GMFM score with a medium effect size (η2 = 0.12). Statistically significant superiority of the INRS treatment over home treatment was also obtained by Jebsen-Taylor Hand Function Test and the Box and Blocks Test in both dominant and non-dominant hands. CONCLUSIONS: The study indicates that the INRS treatment can be beneficial for improving both gross motor functions and hand function in children with bilateral CP. Further longitudinal studies are required to evaluate the effects of the INRS treatment on the participation level of children with CP. TRIAL REGISTRATION: The study protocol was registered on ClinicalTrials.gov under the identifier: NCT04093180 on 17/09/2019.

Yoga for chronic chemotherapy-induced peripheral neuropathy pain: a pilot, randomized controlled trial.

PURPOSE: To determine the feasibility of implementing a yoga intervention for cancer survivors with chronic CIPN pain, as well as the impact of the intervention on patient-reported outcomes. METHODS: Cancer survivors with chronic CIPN pain were recruited from the breast, gastrointestinal, and gynecological oncology centers at Dana-Farber Cancer Institute. Participants were randomized (2:1) to receive an 8-week yoga intervention or usual care. After 21/50 of participants were enrolled, the COVID-19 pandemic required the yoga intervention to be delivered virtually (i.e., Zoom). Pre- and post-intervention, participants self-reported CIPN and co-occurring symptom severity. Adherence to the intervention was defined as practicing ≥ 12 yoga sessions over the 8-week intervention period. Changes in patient-reported outcomes between groups were compared using Wilcoxon's rank-sum tests. RESULTS: Participants (n = 28 yoga, n = 16 control) were mainly female (96%) and diagnosed with stage III/IV disease (66%). Overall, 19/28 (67.8%) of yoga group participants were adherent to the yoga protocol. Yoga group participants experienced significant within-group improvements in all patient-reported outcomes, including worst CIPN pain (median change = - 1.7, p < 0.0001) and sensory CIPN (median change = - 14.8, p < 0.0001), but only improvements in fatigue (p = 0.05) and depression (p = 0.04) were significant compared to the control. There were no differences (p > 0.05) in changes in patient-reported outcomes between in-person (n = 6) or virtual (n = 15) yoga group participants. CONCLUSIONS: Yoga is a feasible non-pharmacological modality for cancer survivors with CIPN, but more information is needed regarding its impact on CIPN and other symptoms. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03824860 IMPLICATIONS FOR CANCER SURVIVORS: Oncology clinicians may consider referring cancer survivors to yoga for chronic CIPN pain, but yoga cannot be currently recommended as an efficacious treatment.

Detecting the extent of control over selection bias relating to oral health and otorhinolaryngology: cross-sectional study

ABSTRACT BACKGROUND: The authors of randomized controlled trials will usually claim that they have met the randomization process criterion. However, sequence generation schemes differ and some schemes that are claimed to be randomized are not genuinely randomized. Even less well understood, and often more difficult to ascertain, is whether the allocation was really concealed. OBJECTIVE: To detect the extent of control over selection bias, in a comparison between two Cochrane groups: oral health and otorhinolaryngology; and to describe the methods used to control for this bias. DESIGN AND SETTING: Cross-sectional study conducted in a public university in São Paulo, Brazil. METHODS: The risk of selection bias in 1,714 records indexed in Medline database up to 2018 was assessed, independent of language and access. Two dimensions implicated in the allocation were considered: generation of the allocation sequence; and allocation concealment. RESULTS: We included 420 randomized controlled trials and all of them were evaluated to detect selection bias. In the sample studied, only 28 properly controlled the selection bias. Lack of control over selection bias was present in 80% of the studies evaluated in both groups. CONCLUSION: The two groups were similar regarding control over selection bias. They are also similar to the methods used. The dimension of allocation concealment appears to be a limiting factor with regard to production of randomized controlled trials with low risk of selection bias. The quality of reporting in studies on oral health and otorhinolaryngology is suboptimal and needs to be improved, in line with other fields of healthcare.

Mediterranean Diet Improves High-Density Lipoprotein Function in High-Cardiovascular-Risk Individuals: A Randomized Controlled Trial.

BACKGROUND: The biological functions of high-density lipoproteins (HDLs) contribute to explaining the cardioprotective role of the lipoprotein beyond quantitative HDL cholesterol levels. A few small-scale interventions with a single antioxidant have improved some HDL functions. However, to date, no long-term, large-scale, randomized controlled trial has been conducted to assess the effects of an antioxidant-rich dietary pattern (such as a traditional Mediterranean diet [TMD]) on HDL function in humans. METHODS: This study was performed in a random subsample of volunteers from the PREDIMED Study (Prevención con Dieta Mediterránea; n=296) after a 1-year intervention. We compared the effects of 2 TMDs, one enriched with virgin olive oil (TMD-VOO; n=100) and the other enriched with nuts (TMD-Nuts; n=100), with respect to a low-fat control diet (n=96). We assessed the effects of both TMDs on the role of HDL particles on reverse cholesterol transport (cholesterol efflux capacity, HDL ability to esterify cholesterol, and cholesteryl ester transfer protein activity), HDL antioxidant properties (paraoxonase-1 arylesterase activity and total HDL antioxidant capacity on low-density lipoproteins), and HDL vasodilatory capacity (HDL ability to induce the release of nitric oxide in endothelial cells). We also studied the effects of a TMD on several HDL quality-related characteristics (HDL particle oxidation, resistance against oxidative modification, main lipid and protein composition, and size distribution). RESULTS: Both TMDs increased cholesterol efflux capacity relative to baseline (P=0.018 and P=0.013 for TMD-VOO and TMD-Nuts, respectively). The TMD-VOO intervention decreased cholesteryl ester transfer protein activity (relative to baseline, P=0.028) and increased HDL ability to esterify cholesterol, paraoxonase-1 arylesterase activity, and HDL vasodilatory capacity (relative to control, P=0.039, P=0.012, and P=0.026, respectively). Adherence to a TMD induced these beneficial changes by improving HDL oxidative status and composition. The 3 diets increased the percentage of large HDL particles (relative to baseline, P<0.001). CONCLUSIONS: The TMD, especially when enriched with virgin olive oil, improved HDL atheroprotective functions in humans. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639.

Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study.

OBJECTIVE: To compare the effects of 2 different injection sites of low doses of botulinum toxin type A with steroid in treating lateral epicondylalgia. DESIGN: Double-blind, randomized, active drug-controlled trial. SETTING: Tertiary medical center. PARTICIPANTS: Patients with lateral epicondylalgia for >6 months were recruited from a hospital-based outpatient population (N=26). A total of 66 patients were approached, and 40 were excluded. No participant withdrew because of adverse effects. INTERVENTIONS: Patients were randomly assigned into 3 groups: (1) botulinum toxin epic group (n=8), who received 20U of botulinum toxin injection into the lateral epicondyle; (2) botulinum toxin tend group (n=7), who received 20U of botulinum toxin injected into tender points of muscles; and (3) steroid group (n=11), who received 40mg of triamcinolone acetonide injected into the lateral epicondyle. MAIN OUTCOME MEASURES: A visual analog scale, a dynamometer, and the Patient-Rated Tennis Elbow Evaluation were used to evaluate the perception of pain, maximal grip strength, and functional status, respectively. Outcome measures were assessed before intervention and at 4, 8, 12, and 16 weeks after treatment. The primary outcome measure was a visual analog scale. RESULTS: At 4 weeks after injection, the steroid group was superior to the botulinum toxin tend group in improvement on the visual analog scale (P=.006), grip strength (P=.03), and Patient-Rated Tennis Elbow Evaluation (P=.02). However, these differences were not observed at the 8-, 12-, and 16-week follow-up assessments. There was no significant difference between the steroid and botulinum toxin epic groups. CONCLUSIONS: Injections with botulinum toxin and steroid effectively reduced pain and improved upper limb function in patients with lateral epicondylalgia for at least 16 weeks. The onset of effect was earlier in the steroid and botulinum toxin epic groups than in the botulinum toxin tend group.

Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.

OBJECTIVE: To examine the effects of 12 weeks of twice-weekly intensive aerobic exercise on physical function and quality of life after subacute stroke. DESIGN: Randomized controlled trial. SETTING: Ambulatory care. PARTICIPANTS: Patients (N=56; 28 women) aged ≥50 years who had a mild stroke (98% ischemic) and were discharged to independent living and enrolled 20 days (median) after stroke onset. INTERVENTIONS: Sixty minutes of group aerobic exercise, including 2 sets of 8 minutes of exercise with intensity up to exertion level 14 or 15 of 20 on the Borg rating of perceived exertion scale, twice weekly for 12 weeks (n=29). The nonintervention group (n=27) received no organized rehabilitation or scheduled physical exercise. MAIN OUTCOME MEASURES: Primary outcome measures included aerobic capacity on the standard ergometer exercise stress test (peak work rate) and walking distance on the 6-minute walk test (6MWT). Secondary outcome measures included maximum walking speed for 10m, balance on the timed Up and Go (TUG) test and single leg stance (SLS), health-related quality of life on the European Quality of Life Scale (EQ-5D), and participation and recovery after stroke on the Stroke Impact Scale (SIS) version 2.0 domains 8 and 9. Participants were evaluated pre- and postintervention. Patient-reported measures were also evaluated at 6-month follow-up. RESULTS: The following improved significantly more in the intervention group (pre- to postintervention): peak work rate (group × time interaction, P=.006), 6MWT (P=.011), maximum walking speed for 10m (P<.001), TUG test (P<.001), SLS right and left (eyes open) (P<.001 and P=.022, respectively), and SLS right (eyes closed) (P=.019). Aerobic exercise was associated with improved EQ-5D scores (visual analog scale, P=.008) and perceived recovery (SIS domain 9, P=.002). These patient-reported improvements persisted at 6-month follow-up. CONCLUSIONS: Intensive aerobic exercise twice weekly early in subacute mild stroke improved aerobic capacity, walking, balance, health-related quality of life, and patient-reported recovery.

Lateral wedge insole for knee osteoarthritis: randomized clinical trial / Palmilha valgizante para osteoartrite de joelhos: ensaio clínico randomizado

CONTEXT AND OBJECTIVE: Optimal management of knee osteoarthritis requires a combination of pharmacological and non-pharmacological methods. The use of lateral wedge insoles to treat medial knee osteoarthritis is recommended, but there is still controversy about its efficacy. The purpose of this study was to ascertain whether the use of lateral wedge insoles can diminish pain and improve function in patients with medial knee osteoarthritis. DESIGN AND SETTING: Prospective randomized trial conducted in a tertiary-level hospital. METHODS: We prospectively enrolled 58 patients with medial knee osteoarthritis and randomized them to use either a lateral wedge insole with subtalar strapping (Group W), or a neutral insole with subtalar strapping (Group N - control). All the patients were instructed to use the insole for five to ten hours per day. A visual analogue pain scale, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Lequesne questionnaire were applied at baseline and at weeks 2, 8 and 24. RESULTS: At weeks 8 and 24, both groups showed lower scores for WOMAC (P = 0,023 and P = 0,012 respectively). There were no statistically significant differences between the groups regarding the visual analogue pain scale, WOMAC or Lequesne results at any time evaluated. CONCLUSION: The use of a lateral wedge insole with subtalar strapping improved the patients' symptoms and function but was not superior ...

CONTEXTO E OBJETIVO: O manejo ideal da osteoartrite de joelhos requer combinação entre modalidades farmacológicas e não farmacológicas. O uso de palmilhas valgizantes no tratamento da osteoartrite medial do joelho é recomendado, mas sua eficácia ainda é controversa. Este estudo objetiva verificar se o uso da palmilha valgizante pode diminuir a dor e melhorar a função dos pacientes com osteoartrite medial dos joelhos. DESENHO E LOCAL: Ensaio clínico prospectivo e randomizado conduzido em hospital de atenção terciária. MÉTODOS: Alocamos prospectivamente 58 pacientes com osteoartrite medial dos joelhos que foram randomizados para fazer uso de palmilha valgizante com amarrilho subtalar (Grupo W) ou palmilha neutra com amarrilho subtalar (Grupo N - controle). Todos os pacientes foram orientados a utilizar a palmilha entre cinco e dez horas por dia. Foram aplicados os questionários Western Ontario and McMaster Universities Arthritis Index (WOMAC) e Lequesne, além da escala visual analógica da dor, nos momentos pré e após 2, 8 e 24 semanas. RESULTADOS: Após 8 e 24 semanas, ambos os grupos apresentaram redução dos valores de WOMAC (P = 0,023 e P = 0,012 respectivamente). Não houve diferença estatisticamente significativa entre os grupos nos resultados de WOMAC, Lequesne e escala visual analógica de dor, em nenhum dos momentos avaliados. ...

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database / Avaliação do risco de viés de ensaios controlados randomizados de odontologia indexados na base de dados Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde)

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22 percent) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

CONTEXTO E OBJETIVO: Ensaios controlados randomizados (ECRs) bem conduzidos representam o mais alto nível de evidência quando a pergunta de pesquisa é sobre o efeito de intervenções terapêuticas ou preventivas. No entanto, o grau de controle de viés entre os ECRs apresenta grande variabilidade entre estudos. Por esta razão, com o aumento do interesse e produção das revisões sistemáticas e metanálises, foi necessário desenvolver metodologia suportada por evidência empírica, para incentivar e valorizar a produção de ECRs válidos e com baixo risco de viés. O objetivo deste trabalho foi realizar uma análise metodológica da área de odontologia quanto ao risco de viés de ECRs de acesso aberto, disponibilizados no banco de dados do Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde). TIPO DE ESTUDO E LOCAL: Trata-se de um estudo sobre metodologia conduzido na Universidade Federal de São Paulo (Unifesp) que avaliou o risco de viés dos ECRs, utilizando as seguintes dimensões: geração da sequência de alocação, sigilo da alocação, cegamento e dados sobre desfechos incompletos. RESULTADOS: Dos 4.503 artigos classificados somente 10 (0,22 por cento) estudos foram considerados verdadeiros ECR e, destes, somente um estudo foi classificado como sendo de baixo risco de viés. Os itens mais frequentemente controlados pelos autores dos ECR foram cegamento e dados sobre desfechos incompletos. CONCLUSÃO: A presença efetiva de viés enfraqueceu seriamente a confiança nos resultados dos estudos de odontologia avaliados, sendo pouco úteis para clínicos e gestores como suporte a processos de decisão.

Influence of bromopride in the prophylaxis of nausea associated with fluorescein angiography

PURPOSES: To determine the efficacy of bromopride in the prophylaxis of nausea during fluorescein angiography, when compared with a placebo. METHODS: The study was a double-masked random clinical trial, between December of 2004 and April of 2005. Examinations were performed with 20 percent intravenous fluorescein sodium in a single dose of 2.5 ml. The patients were divided into two groups: group 1, patients who received a 2 ml intravenous dose of 5 mg/ml bromopride and group 2, patients who received a 2 ml intravenous dose of 0.9 percent sodium chloride (placebo), both 20 minutes before the dye injection. Cases of nausea were observed during and after the examination. RESULTS: 352 patients were enrolled, 176 in each group. Cases of nausea were observed in 12 (6.8 percent) patients of the bromopride group and in 11 (6.3 percent) patients of the placebo group (p<0.829 - relative risk=1.05). CONCLUSION: Bromopride did not prevent the occurrence of nausea in fluorescein angiography, when compared with a placebo.

OBJETIVOS: Determinar a eficiência da bromoprida na profilaxia de náuseas na angiofluoresceinografia, quando comparada a um placebo. MÉTODOS: O estudo foi um ensaio clínico aleatório duplo-mascarado, entre dezembro de 2004 e abril de 2005. Os exames foram realizados com fluoresceína sódica a 20 por cento intravenosa em dose única de 2,5 ml. Os pacientes foram divididos em dois grupos: grupo 1, pacientes que receberam 10 mg/ 2 ml de bromoprida via intravenosa e o grupo 2, pacientes que receberam uma dose 2 ml de cloreto de sódio a 0,9 por cento (placebo), ambos 20 minutos antes da injeção do contraste. Foram registrados os casos de náusea durante e após o exame. RESULTADOS: Foram selecionados 352 pacientes, 176 em cada grupo. Foram registrados casos de náusea em 12 (6,8 por cento) pacientes do grupo da bromoprida e 11 (6,3 por cento) pacientes do grupo placebo (p<0,829 - risco relativo=1,09). CONCLUSÃO: Neste estudo a bromoprida não preveniu a ocorrência de náuseas na angiofluoresceinografia, quando comparada a um placebo.